CN103055404A - Plasma-treated dialysis catheter cuff - Google Patents

Plasma-treated dialysis catheter cuff Download PDF

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Publication number
CN103055404A
CN103055404A CN2012104487296A CN201210448729A CN103055404A CN 103055404 A CN103055404 A CN 103055404A CN 2012104487296 A CN2012104487296 A CN 2012104487296A CN 201210448729 A CN201210448729 A CN 201210448729A CN 103055404 A CN103055404 A CN 103055404A
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CN
China
Prior art keywords
conduit
big envelope
plasma
oxygen
tubular body
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN2012104487296A
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Chinese (zh)
Inventor
M-S·谢乌
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Covidien LP
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Tyco Healthcare Group LP
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Publication date
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Publication of CN103055404A publication Critical patent/CN103055404A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3653Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659Cannulae pertaining to extracorporeal circulation
    • A61M1/3661Cannulae pertaining to extracorporeal circulation for haemodialysis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04Macromolecular materials
    • A61L29/06Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3653Interfaces between patient blood circulation and extra-corporal blood circuit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3653Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659Cannulae pertaining to extracorporeal circulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M25/0029Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/18Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M2025/0004Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
    • A61M2025/0006Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system which can be secured against axial movement, e.g. by using a locking cuff

Abstract

A catheter is disclosed. The catheter includes an elongated tubular body defining a longitudinal axis and extending to a distal end thereof, the tubular body having at least one lumen and a cuff disposed around the tubular body configured to contact tissue, the cuff formed from a plasma-treated material having enhanced tissue ingrowth properties.

Description

Plasma treated dialysis catheter big envelope
Technical field
The present invention relates to medical conduit, especially relate to the conduit that comprises the plasma treated big envelope of growth characteristics in the tissue with enhancing.
Background technology
In some Medical Treatment, for fluid is implemented in the body and/or in body, remove body fluid be used for purifying, test, monitoring or the purpose processed, expectation be to set up the long-term blood vessel access that leads to specific desired area in the body.
Particularly in long-time continuous or periodically fluid is implemented in the body or in the body in the situation of removing fluids, at the known use of medical field " forever " catheter technique, this technology adopts the equipment (such as hemodialysis catheter and tunnel type venous duct (CVCs)) of subcutaneous implantation to continue several weeks to the several years.In US patent 7,141,035 and 7,777, find the example of this subcutaneous implantation and relevant armarium in 605, the whole content of described patent is by with reference to incorporating into.Need thisly continuously or periodically to comprise parenteral feeding, chemotherapy, enforcement antibiotic, dialysis etc. near the example of the therapeutic scheme of ad-hoc location in the body for a long time.
Typically, conduit is the armarium of tubulose flexibility, and it has one or more inner chambers, for example two inner chambers or three inner chambers.Many lumen catheter help fluid to flow at both direction, and for example inner chamber is carried out withdrawing from of blood and blood that another inner chamber will be processed is introduced blood vessel more thus.In the hemodialysis operation of example, many lumen catheter are inserted in the body, blood is withdrawn from by the arterial lumens of conduit.These blood are fed into hemodialysis unit, and this hemodialysis unit is dialysed or purified the blood to remove rubbish and unnecessary water.The blood of dialysing returns the patient by the vein inner chamber of conduit.Typically, vein inner chamber and arterial lumens separate by the interior catheter wall that is called barrier film.
In some other medical conduit equipment of level (for example peritoneal dialysis catheters), promote epidermal tissue can provide a lot of benefits around big envelope or the lip growth of equipment.Epidermis is that human body supports the anti-infective natural cover for defense, also is the habitat that causes the microorganism largest container of catheter-related Infections: Clinical Study.A series of physiological mechanisms that the on-stream setting of the wound of epidermis (for example conduit inserts required otch in the body) is intended to healing of wound and rebuilds the ability that skin protects from infection.Understand these natural mechanism in depth, and the conduit that has the big envelope technology at cutting part place equipment provides available strategy to reduce the sickness rate relevant with conduit and cost to help being successfully completed these natural immunology defense.Therefore, be desirable to provide the conduit big envelope with growth performance in the improved tissue.
Summary of the invention
The invention provides a kind of conduit.This conduit comprises the elongate tubular body that limits longitudinal axis and one or more inner chambers, and described tubular body has far-end and near-end.This conduit also comprises the big envelope of arranging around tubular body, and described big envelope is configured to contact tissue, and described big envelope is made by plasma treated material.
In an embodiment, a kind of method for Cement Composite Treated by Plasma conduit big envelope is also disclosed.The method comprises that the mixture with oxygen and at least a hydrocarbon gas is supplied in the plasma chamber; The point burning mixt is to form plasma; And directing plasma is to the conduit big envelope.
In other embodiments, a kind of method for Cement Composite Treated by Plasma conduit big envelope is also disclosed.The method comprises with the mixture of the combination flow velocity from about 15sccm to about 40sccm with oxygen and methane and being supplied to the plasma chamber; The point burning mixt is to form plasma; And directing plasma to the conduit big envelope about 1 minute to about 5 minutes.
Description of drawings
Describe various embodiments of the present invention with reference to the accompanying drawings at this, wherein:
Fig. 1 shows the axonometric chart according to duct portion of the present invention cross section;
Fig. 2 shows along the cross sectional elevation of the hatching 2-2 of Fig. 1;
Fig. 3 shows the photo of the mouse of the conduit of having implanted Fig. 1;
Fig. 4 shows 7 days afterwards from the photo of the cross-sectional slice of the plasma treated conduit big envelope of conduit of implanting mouse and untreated conduit big envelope;
Fig. 5 shows the block diagram of the Premeabilisation of cells in the conduit big envelope that is penetrated into Fig. 4;
Fig. 6 shows the block diagram of the cell density in the conduit big envelope of Fig. 4;
Fig. 7 shows collagenogenic block diagram in the conduit big envelope of Fig. 4;
Fig. 8 shows the block diagram of tissue adhesion power of the conduit big envelope of Fig. 4; And
Fig. 9 shows the interior growth of the tissue chart in time of the conduit big envelope of Fig. 4.
The specific embodiment
The exemplary embodiment of disclosed conduit and using method is to discuss according to medical conduit that be used for to implement the fluid such as (withdraw from, introducing) and enter and/or leave human body.Conduit advantageously is configured to help fluid reversible flowing between the chamber within it.What envision is, the present invention can use with a series of conduits, for example hemodialysis, peritoneum, infusion, PICC, CVC and port and comprise the conduit application scenario that disease and the health slight illness of object are carried out operative treatment, diagnoses and treatment and associated treatment.What can also envision is, comprises the operation of adopting various conduits relevant about the principle of disclosed conduit, for example in the chronic and acute application scenario of hemodialysis, heart, abdominal part, urinary system and intestinal.
In ensuing discussion, term " closely " refers to the close doctor's of a structure part, and term " far " refers to the part away from the doctor.Use herein, term " object " refers to human patients or other animal.According to the present invention, term " doctor " refers to doctor, nurse or other nursing suppliers and can comprise the paraprofessional personnel
Referring now to accompanying drawing, wherein similar assembly adopts similar Reference numeral in a plurality of views, and Fig. 1 figure has released the exemplary hemodialysis catheter assembly 10 according to the principle of the invention.Conduit tube component 10 comprises the sheathed catheter joint 12 of the far-end 12a that has separately and near-end 12b, from the sheathed catheter joint 12 slender conduit members 14 to remote extension, from sheathed catheter joint 12 the first and second extensions 16,18 to proximal extension.Conduit tube component 10 can be provided with the cover joint 12 integrally formed with catheter component 14.Perhaps, cover joint 12 can be configured to be attached to catheter component 14 after the doctor inserts conduit in the patient body.Conduit tube component 10 also comprises can be around the pair of jaws 20 of extension 16,18 location.Each clamp 20 can move on to basically closed position compressing corresponding extension 16,18 from open position, and forbids that thus flow crosses extension 16,18.Each extension 16,18 comprises for the adapter 74 that is connected to haemodialysis equipment in the proximal end.
Sheathed catheter joint 12 is configured to and is designed and sized to by the doctor to be caught, and comprises nearside (afterbody) shell section 22 of contiguous extension 16,18 location, and distally (front portion) shell section 24 of adjacent pipes member 14 location.Proximal housing section 22 is suitable for receiving the first and second extensions 16,18 with fixing relation respectively.For example, extension 16,18 can be fixed in the separately extension conduit (not shown) of sheathed catheter joint 12 by adopting interference fit or frictional fit, cement, binding agent or other any suitable mode.The distally shell section 24 of sheathed catheter joint 12 limits the central opening (not shown), described central opening is configured to and is designed and sized to fixing relation and receives catheter component 14, for example by adopting interference fit or frictional fit, cement, binding agent or other any suitable mode.
Among the embodiment of the illustrated conduit tube component 10 of Fig. 1, sheathed catheter joint 12 also comprises from the sheathed catheter joint 12 a pair of relative wings 26 that outwards dangle.The wing 26 can be around fixing surface, to save 12 with respect to patient's A/C cover as one or more stitching thread (not shown).Perhaps, the wing 26 or sheathed catheter joint 12 can comprise the cannelure (not shown) in its outer surface, and this cannelure is configured to and is designed and sized to the receiving slot zygonema, and like this, stitching thread can be positioned in the cannelure, and is fixed to the patient subsequently.
Referring to Fig. 1 and Fig. 2, catheter component 14 comprises outer wall 28, and limits longitudinal axis " X ".What can envision is that if need or expectation, the outer wall 28 of catheter component 14 can comprise that reinforcement material increases its stability and rigidity.As shown in Figure 2, in one embodiment of the invention, catheter component 14 can adopt two inner chamber structures, this pair inner chamber structure comprises by septum wall 34 separated separately the first and second inner chambers 30,32, this septum wall 34 can be extended or not extend along the length of catheter component 14 along the length of catheter component 14.In this embodiment, first and second vertical inner chambers 30 separately, 32 are configured to all and are designed and sized to that fluid is communicated with between the near-end of catheter component 14 and far-end, and can comprise any cross-sectional configuration that is suitable for this plan purpose, comprise but do not limit ellipse, kidney shape, D shape, annular, cheese etc.Yet what can envision is, inner chamber 30 or 32 can play introducing (tremulous pulse) inner chamber or return the effect of (vein) inner chamber, and in the discussion below all, inner chamber 30 refers to the vein inner chamber, and inner chamber 32 refers to arterial lumens.Although be illustrated as side by side orientation among Fig. 2, inner chamber 30,32 can also be to locate coaxially.
On (far) end 38, catheter tip member 40 advantageously was configured to and is designed and sized to and helps to insert in the tissue at first before (far) end 38 before catheter component 14 also comprises, catheter tip member 40 formed or are installed on front (far) end 38 integral body.In an embodiment, pointed member 40 can be that disclosed inaccessible opposing is most advanced and sophisticated in the United States Patent (USP) 7,141,035 and 7,777,605 of owning together, and the whole content of described patent is incorporated at this by reference.
Referring to Fig. 1, catheter component 14 also comprises the big envelope 72 of arranging around catheter component 14.The subcutaneous interior growth that the position of big envelope 72 in catheter component 14 patients with implantations is provided for organizing is kept somewhere in the position so that conduit tube component 10 is fixed on for a long time.Big envelope 72 neutralizations physically are fixed on catheter component 14 in the patient body around the interior growth of the tissue of big envelope 72, and the anti-infective Additional Protection is provided.Need not by the restriction of any particular theory, what can believe is, around the formation of the fibrous tissue of big envelope 72 as stop antibacterial and other foreign materials and organism enter implant site barrier.Therefore, expectation is around the fast interior growth of tissue of big envelope 72.
The DACRON by name that big envelope 72 can adopt the Invista of Wichita, the Kansas State to sell TMPolyethylene terephthalate make.Yet big envelope 72 also can adopt and comprise and can absorb or the biocompatible materials of any appropriate of nonabsorable material is made.As used herein, term " can absorb " but comprise the material of biodegradable and bio-absorbable and be illustrated in and decompose under people's concrete conditions in the establishment of a specific crime or (for example lose structural integrity, enzymatic degradation, hydrolysis) material or (for example destroyed by (physically or chemically) under the physiological condition in vivo, dissolving) material is so that catabolite can be discharged or absorption by human body.
Suitable absorbable material can comprise polymer, such as aliphatic polyester; Polyamide; Polyamine; The polyalkylene oxalate; Poly-(acid anhydride); The polyamidoamines ester; Copolymerization (ether-ester); Poly-(carbonic ester) that comprises the carbonic ester of tyrosine-derived; Poly-(hydroxy alkane acid ester) such as poly-(hydroxybutyric acid); Poly-(hydroxypentanoic acid) and poly-(butyric ester); The polyimides carbonic ester; Such as poly-(poly-(iminocarbonic ester) of bisphenol-A-iminocarbonic acid etc.; Poe; Polyoxaesters comprises those that contain amido; Polyurethane; With and the combination.
Other suitable biodegradable polymers can include but not limited to: poly-(aminoacid) comprises such as collagen (I, II and III), elastin laminin, fibrin, Fibrinogen, silk and albuminous protein; Peptide comprises the sequence of laminin,LN and fibronectin (RGD); Polysaccharide is such as hyaluronic acid (HA), dextran, alginate, chitin, chitosan and cellulose; Glycosaminoglycan; Internal organs; With and the combination.
Adoptable suitable nonabsorable material can comprise among the present invention: polyolefin such as polyethylene (comprising ultra-high molecular weight polyethylene) and polypropylene, comprises atactic, isotaxy, syndiotaxy and their mixture; Polyethylene Glycol; Silicone rubber, silicones and polysiloxanes are such as polydimethylsiloxane and polydiphenylsiloxane; Polyethylene oxide; Ultra-high molecular weight polyethylene; Polyethylene and polyacrylic copolymer; Polyisobutylene and ethene-alpha-olefin copolymer; Fluorinated polyolefin is such as fluorothene, fluorine propylene, fluoro Polyethylene Glycol and politef; Polyamide is such as nylon, nylon 6, nylon 6,6, nylon 6,10, nylon 11, nylon 12 and polycaprolactam; Polyamine; Poly-imines; Polyester is such as polyethylene p-phthalic acid, PEN, polytrimethylene p-phthalic acid and polybutene p-phthalic acid; Polyethers; Poly-butyl ester; Polytetramethylene ether diol; BDO; Polyurethane; Acrylic polymer; Methacrylate; The polymer of vinyl halide and copolymer are such as polrvinyl chloride; Polyvinyl alcohol; Polyvingl ether is such as polyvinyl methyl ether; Poly-inclined to one side dihalide is such as polyvinylidene fluoride and polyvinylidene chloride; The polychlorostyrene fluorothene; Polyacrylonitrile; PAEK; Polyvinyl ketone; The polyvinyl aromatic compounds is such as polystyrene; Polyvinyl ester is such as polyvinyl acetate; Vinyl monomer each other with the copolymer of alkene, such as the ethylene-methyl methacrylate methyl terpolymer; Acrylonitritrile-styrene resin; ABS resin; Vinyl-vinyl acetate copolymer; Alkyd resins; Merlon; Polyformaldehyde; Polyphosphazene; Polyimides; Epoxy resin; Aromatic polyamides; Viscose glue; The viscose glue triacetate; Spandex; Siloxanes; With and copolymer and combination.
In certain embodiments, absorbable material and nonabsorable material all can be used for making big envelope 72.Big envelope 72 can comprise absorbable material alternately and the multiple structure of nonabsorable material.In other embodiments, big envelope 72 can be made by non-woven material (for example similar felt) or porous material.
The invention provides a kind of system and method for using Cement Composite Treated by Plasma big envelope 72, thus the faster interior growth that makes big envelope 72 be easier to organize with the material that changes big envelope 72.As used herein term " plasma " refer to its essential part be ionization and any material of being gaseous form.
In an embodiment, can produce plasma with the electric energy that is delivered to ionizable medium.Can use suitable electromotor, electrode and antenna with from about 0.1MHz to about 2, the frequency of 450MHz and in another embodiment the frequency from about 1MHz to about 160MHz, with continuous mode or pulse mode, to exchange form electric energy transmitting of (AC) electricity.The average energy that is transferred to ionizable medium can be from about 10 watts (W) to about 1000W, in an embodiment can be from about 50W to about 200W.
Ionizable medium can be any suitable constituent, forms gaseous state, the liquid state or solid-state of plasma when it can be ionization.Liquid state or solid body can adopt aerosol apparatus, microfluidic device, piezoelectric pump, ultrasonic vaporizer etc. to atomize or spray.The example of suitable ionizable medium includes but not limited to argon, helium, neon, krypton, xenon, radon, carbon dioxide, nitrogen, hydrogen, oxygen, the hydrocarbon gas (such as methane, ethane, propane, butane) and their combination.
Ionizable medium can with from about 1 standard cubic centimeter per minute (sccm) to the flow velocity of about 100sccm, can be the flow velocity input plasma chamber from about 5sccm to about 35sccm in an embodiment.If the use multiple gases then can be transmitted every kind of gas with any required ratio by being that every kind of gas and changing flow velocity is next.Pressure in the plasma chamber can be from about 50 millitorrs (mTorr) to about 2000mTorr, can be to about 1000mTorr in an embodiment from about 500mTorr.In an embodiment, plasma can be applied on the big envelope 72 about 10 seconds to about 20 minutes, about 1 minute to about 5 minutes in an embodiment.Perhaps, envision other plasma application time.
In an embodiment, can form plasma by the mixture of ionization oxygen and one or more hydrocarbon gas.Flow velocity that can be from about 1sccm to about 10sccm, can be that flow velocity from about 3sccm to about 6sccm provides oxygen in an embodiment.Flow velocity that can be from about 15sccm to about 30sccm, can be that flow velocity from about 20sccm to about 25sccm provides the hydrocarbon gas in an embodiment.The combination flow velocity of oxygen and the hydrocarbon gas can be from about 15sccm to about 40sccm, can be to about 35sccm from about 20sccm among the embodiment.In other embodiments, flow velocity that can any appropriate provides gas, so that the ratio of oxygen and one or more hydrocarbon gas is from about 1: 1 to about 1: 10, this ratio is from about 1: 4 to about 1: 5 in an embodiment.
Need not to stick to any particular theory, what can believe is, based on the application of the plasma of oxygen and the hydrocarbon gas by making the big envelope 72 more hydrophilic chemical characteristics that change big envelope 72, thereby promote the faster interior growth of tissue.Especially, the application of plasma adds oxidation panel (such as hydroxyl, ether, ester, carbonyl etc.) by the material surface at big envelope 72 and causes the material of big envelope 72 oxidized.Plasma treated big envelope 72 provides the tissue of enhancing interior growth characteristics, comprises tissue penetration (being the degree of depth), cell density, collagenation and tissue adhesion intensity.
List following example and explain embodiments of the invention.These examples are intended to only explain but not limit the scope of the invention.And if do not indicate in addition, part and percentage ratio are by weight." room temperature " or " ambient temperature " here used refers to about 20 ℃ and arrives about 25 ℃ temperature.
Example
Example 1-DACRON TM The Cement Composite Treated by Plasma of conduit big envelope
Employing is processed DACRON from the PJ plasma surface treatment device of card AST Products in the Bill of Massachusetts TMBig envelope.Use the oxygen that provides with about 5sccm flow velocity and the methane that provides with about 25sccm flow velocity to generate plasma.The pressure of plasma intracavity approximately is 430mTorr.The energy of supplying with is approximately 100W.Big envelope was processed about 5 minutes.
Also use the oxygen that provides with about 10sccm flow velocity and the methane that provides with about 25sccm flow velocity to generate plasma.The pressure of plasma intracavity approximately is 465mTorr.The energy of supplying with is approximately 120W.Big envelope was processed about 5 minutes.
Also use the oxygen that the flow velocity with about 5sccm provides and the methane that provides with about 20sccm flow velocity to generate plasma.The pressure of plasma intracavity approximately is 388mTorr.The energy of supplying with is approximately 100W.Big envelope was processed about 5 minutes.
The subcutaneous implantation of example 2-hemodialysis catheter
In the subcutaneous implantation mouse body of conduit, grow in the tissue of two (2) hemodialysis catheters of each animal (for example control and test conduit) with more different conduit envelope material.Every mouse is implanted has typical DACRON TMBig envelope is as the first conduit of controller, and the second conduit that comprises the plasma treated big envelope of example 1.As shown in Figure 3, conduit is implanted to about seven (7) days (group I) and about 28 (28) days (organizing II) in the back of animal.
At first take out a group in the conduit after seven (7) days, and second group of conduit taking-up in 28 (28) days after implantation.Obtain the slices across of big envelope and observe at the about microscopically of 200X amplification.
Fig. 4 figure has released the plasma treated DACRON by example 1 that takes out after seven (7) days TMThe big envelope of making and by untreated DACRON TMThe image of the big envelope that material is made.The observed result of record organization infiltration in the block diagram of Fig. 5, Fig. 5 comes figure to release the tissue infiltration based on the tissue thickness in micron (μ m).The DACRON that is untreated and processed TMBig envelope showed similarly tissue infiltration after seven (7) days.
It also is the cell density of growth in each conduit survey map 4 illustrated tissue.The observed result of growing in the record organization in the block diagram of Fig. 6, Fig. 6 is based on the measured cell density (cell quantity (cells/mm of per unit area 2)) come figure to release the tissue infiltration.The untreated big envelope of comparing, aspect cell density and tissue thickness's measurement, the plasma treated DACRON of example 1 TMBig envelope demonstrates maximum cell density after implanting seven (7) days.
Except assessment tissue thickness and cell density, the generation of also having compared the collagen of different big envelopes.Fig. 7 figure has released based on collagenogenic tissue infiltration (percentage of coverage).Equally, the untreated big envelope of comparing, plasma treated DACRON TMBig envelope demonstrates larger collagen density after implanting seven (7) days.
Also come the effect of growth in the test organization by the tissue adhesion intensity (for example removing the required pulling force of conduit) of measuring big envelope.The bonding observed result of record organization in the block diagram of Fig. 8, Fig. 8 comes figure to release tissue adhesion with the pulling force aspect that newton (N) measures.The untreated big envelope of comparing, plasma treated DACRON TMBig envelope demonstrates larger tissue adhesion after implanting seven (7) days.
The block diagram of Fig. 5-8 the results are summarized in the chart of Fig. 9, and Fig. 9 figure has released tissue growth in time.Shown in the chart among Fig. 9, plasma treated DACRON TMBig envelope is than untreated DACRON TMBig envelope is with level of growth in the higher tissue of faster ratio arrival.Therefore, find plasma treated DACRON TMBig envelope provides growth in the greater amount tissue that can faster ratio reaches.
Although discussed by DACRON uniquely at this TMThe conduit big envelope of making, what still believe is that other material (including but not limited to Poly(D,L-lactide-co-glycolide, silicone rubber and chitosan) can be benefited from Cement Composite Treated by Plasma aspect the growth characteristics equally in strengthening tissue.
In addition, although at this use of plasma treated big envelope has been discussed in conjunction with two inner chamber hemodialysis catheters, but be anticipated that, advantage about plasma treated big envelope disclosed herein may be used on various conduits (comprising single lumen catheter and many lumen catheter), and described conduit can be benefited from the use of big envelope in long-term conduit inserts.Therefore, although at this illustrated embodiment of the present invention has been described with reference to the drawings, foregoing description, open and accompanying drawing are not interpreted as restriction, and only are the examples of specific embodiment.Therefore, be understandable that the present invention is not subject to those clear and definite embodiment, and those skilled in the art do not depart from the scope of the present invention or the situation of spirit under can carry out various other changes and distortion to it.

Claims (15)

1. conduit, it comprises:
Elongate tubular body, described elongate tubular body limits longitudinal axis and at least one inner chamber, and described tubular body has far-end and near-end; And
Around the big envelope that described tubular body is arranged, described big envelope is configured to contact tissue, and described big envelope is formed by plasma treated material.
2. conduit as claimed in claim 1, wherein said conduit are the hemodialysis catheters that is configured in the implanting tissue.
3. conduit as claimed in claim 1, wherein said big envelope is formed by absorbable material.
4. conduit as claimed in claim 1, wherein said big envelope is formed by the nonabsorable material.
5. conduit as claimed in claim 4, wherein said nonabsorable material is polyethylene terephthalate.
6. conduit as claimed in claim 1, wherein said big envelope comprise a plurality of layers, and wherein at least one layer is formed by absorbable material, and at least one other layer formed by the nonabsorable material.
7. conduit as claimed in claim 1, wherein said big envelope is processed by the oxygen of ionization and the plasma of at least a hydrocarbon gas, and the described hydrocarbon gas is selected from by methane, ethane, propane, butane and the group that constitutes thereof.
8. method that is used for Cement Composite Treated by Plasma conduit big envelope, the method comprises:
The mixture of oxygen and at least a hydrocarbon gas is supplied in the plasma chamber;
The point burning mixt is to form plasma; And
Directing plasma is to the conduit big envelope.
9. method as claimed in claim 8, the pressure in the wherein said plasma chamber remain on about 50mTorr to about 2000mTorr, and the ratio of oxygen and the described at least a hydrocarbon gas is from about 1: 4 to about 1: 5.
10. method as claimed in claim 8 wherein guides step to occur from about 10 seconds to about 20 minutes time cycle.
11. method as claimed in claim 8, wherein said big envelope is formed by the material that is selected from following group, and described group by PLGA, polyethylene terephthalate, silicone rubber, chitosan and constitute.
12. a method that is used for Cement Composite Treated by Plasma conduit big envelope, it comprises:
Supply to the plasma chamber with the mixture of the combination flow velocity from about 15sccm to about 40sccm with oxygen and methane;
The point burning mixt is to form plasma; And
Directing plasma to the conduit big envelope about 1 minute to about 5 minutes.
13. method as claimed in claim 12, the pressure in the wherein said plasma chamber remain on about S0mTorr to about 2000mTorr, and the ratio of oxygen and methane is from about 1: 4 to about 1: 5.
14. method as claimed in claim 12 is wherein lighted step and is comprised and will have electric energy from about 10W to about 1000W average energy and supply to the mixture of oxygen and methane.
15. method as claimed in claim 12, wherein said big envelope is formed by polyethylene terephthalate.
CN2012104487296A 2011-09-29 2012-09-28 Plasma-treated dialysis catheter cuff Pending CN103055404A (en)

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